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Research Article CODEN: IJPRNK ISSN: 2277-8713 Bathini Srinivas, IJPRBS, 2015; Volume 4(6): 213-228 IJPRBS

Available Online at www.ijprbs.com 213

SPCTROPHOTOMETRIC DETERMINATION OF DRUGS IN BULK AND

PHARMACEUTICAL DOSAGE FORM BY USING P-CHLORANILIC ACID

BATHINI.SRINIVAS, P. YADAGIRISWAMY, G. VENKATESWARLU

Department of chemistry, University College of Science, Osmania University, Hyderabad,

500007, India.

Accepted Date: 03/12/2015; Published Date: 27/12/2015

Abstract: Simple, sensitive and accurate UV-Visible Spectrophotometric methods have been developed for the determination of following drugs viz,. Vilazodone hydrochloride (VLZ), Dronedarone hydrochloride(DND), Brinzolamide(BNZ), Donepezile hydrochloride(DPZ) and Fexofenadine methyl ester(FME) in bulk and their dosage forms using p-Chloranilic acid as analytical reagent. The methods have been developed based on the formation of charge transfer complex of drugs as n-electron donor with p-Chloranilic acid as π acceptor. The selected drugs turned the pale yellow color of reagent viz., p-chloranilic acid in acetonitrile, to purple and exhibited a band at 515nm due to anion of the reagent whose intensity increased with increase in the concentration of the drugs. Under the optimized experimental conditions, Beer’s law is obeyed over the concentration range of, 15-75µg/ml, 5-25µg/ml, 5-25µg/ml, 5-25µg/ml and 10-50µg/ml for, VLZ, DND, BNZ, DPZ and FME respectively. The effect of reagent concentrations, polarity of solvents and effect of reaction time have been studied and optimized. The composition of each complex is found to be 1:1. These methods have been validated in terms of ICH guidelines and applied to the quantification of selected drugs in bulk and dosage forms. Keywords: Drugs, Spectrophotometry, p-Chloraniliac acid, Quantification, Validation.

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Corresponding Author: MR. BATHINI. SRINIVAS

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Bathini Srinivas, IJPRBS, 2015; Volume 4(6): 213-228



INTRODUCTION

Vilazodone hydrochloride: Vilazodone, 5-{4-[4-(5-cyano-1H-indol-3-yl)butyl]piperazin-1-

yl}benzofuran-2-carboxamide, is a new antidepressant that was developed for the treatment of

major depressive disorder[1].It is a selective serotonin reuptake inhibitor (SSRI) and a 5-HT1A

receptor partial agonist used for the treatment of major depressive disorder [2].

Literature search reveals that there are a few analytical methods have been developed for the

determination of Vilazodone hydrochloride like spectrophotometry, RP-HPLC, Stability

indicating RP-HPLC, Isolation and structure elucidation by HPLC, RP-HPLC with Fluorimetric

Detection and LC-MS/MS [3].

Dronedarone hydrochloride: Dronedarone chemically known as N-{2-butyl-3-[4-(3-

dibutylaminopropoxy) benzoyl]-benzofuran-5-yl} methanesulfonamide, is a potent drug mainly

used for the indication of cardiac arrhythmias [4]. Dronedarone is a multi-ion channel blocker,

inhibiting the potassium currents involved in cardiac re- polarization including IKr, IKs, IKur, and

IK (Ach) and has been shown to be effective in the treatment of cardio- vascular hospitalization

in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL) [5-8].

A literature survey revealed that there are a few analytical methods were available for the

investigation of pharmacokinetics of dronedarone like liquid chromatography-tandem mass

spectrometry[9], HPLC-UV[10], Stability indicating HPLC [11], UV spectrophotometry [12].

Brinzolamide: Brinzolamide (BRZ), [(R)-(+)-4-Ethylamino-2-(3-methoxypropyl)-3, 4-dihydro-2H

thieno [3,2-e]-1,2-thiazine-6-sulfonamide-1,1-dioxide], is a new active substance which is useful

only for topical use in the treatment of glaucoma[13]. BRZ has been marketed in combination

with TM in eye drops for treatment of glaucoma, which have lesser side effects and patient

specificity compared to previous eye drops, DORZOX-T (dorzolamide and timolol maleate) [14].

Literature search reveals that there are a few analytical methods have been developed for the

determination of Brinzolamide like Stereo-Selective HPLC [15], Spectrophotometry [16].

Donepezile hydrochloride:

Donepezil hydrochloride chemically known as (±)-2,3-dihydro-5,6-dimethoxy 2-[[1-(phenyl

methyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride [17]. Donepezil hydrochloride

(DH) is a specific and reversible inhibitor of acetyl cholinesterase, and used in the treatment of

Alzheimer’s disease [18].

Through Survey of Literature reveals that a few methods were reported for the determination

of Donepezil like ultraviolet (UV) visible spectrophotometry, HPLC, (LC-MS)-MS, HPTLC [19].



Fexofenadine methyl ester: Fexofenadine α, α-dimethyl-4-[1-hydroxy-4-[4-(hydroxydiphenyl-

methyl)-1-piperidinyl] butyl]-benzene acetic acid [20], is the active carboxylic acid analogue of

the antihistamine terfenadine. It shares the histamine H1 receptor antagonist and non-sedative

properties of the parent compound. This could be attributed to its capability to exist in zwitter-

ionic form so it cannot pass through blood-brain barrier and therefore does not cause sedation

[21, 22].

Literature search reveals that there are a few methods reported like LC-MS/MS [23], ultraviolet

detection [24] and fluorescence detection [25]. Spectrophotometry [26], LC methods with

ultraviolet detection [27-29], capillary electrophoresis [30, 31].

Thorough survey of literature on the selected drugs revealed that quantification using p-CA as

analytical reagent has not been reported yet. This paper reports simple, direct, and sensitive

spectrophotometric method for determination of selected drugs using p-CA as π-acceptor

based on the formation of charge transfer complex.

EXPERIMENTAL

Instrument: Shimadzu 2600 double beam UV-Visible spectrophotometer, UV-3600

ShimadzuUV-VIS-NIR Spectrophotometer & Elico 159 UV-Visible single beam

spectrophotometers were used to record the spectra of individual components as well as the

charge transfer complexes, using matched pair of Quartz cells of 10mm path length.

Materials: The p-Chloranilic acid was supplied by sigma Aldrich. The AR grade solvents viz.,

acetonitrile, methanol and chloroform are supplied by SD Fine chem. Ltd. Mumbai, India. The

drugs used in present study were procured from Hetero drugs pvt.ltd. Hyderabad and the

pharmaceutical dosage forms of drugs were purchased from the local market.

Vilazodone hydrochloride Dronedarone hydrochloride



Brinzolamide

Donepezile hydrochloride Fexofenadine methyl ester

N

O

O

Cl

OH

HO

Cl

N

O

O

Cl

OH

HO

Cl

O

Cl

OH

O

Cl

HO

N

Drug s p-CA Charge transfer complex anion cation

Fig. (1): Vilazodone hydrochloride in acetonitrile, (2) p-Chloranilic acid in acetonitrile &

(3) Charge transfer complex spectra of Vilazodone with p-CA.

200 300 400 500 600 700 800

0.0

0.2

0.4

0.6

0.8

1.0

1.2

Abso

rban

ce

Wavelength(nm)

3

2

1

https://en.wikipedia.org/wiki/File:Brinzolamide.svg

https://en.wikipedia.org/wiki/File:Donepezil_skeletal.svg



PREPARATION OF STANDARD STOCK SOLUTION

For VLZ, DND & DPZ: An accurate weight of drugs (100mg) were weighed and dissolved in

distilled water in a 100ml of standard flask and transferred into a 125ml separating funnel,

where 15 ml of 0.1N NaOH solution were added. The mixture was mixed and extracted three

times with 20ml of CHCl3 each, then the chloroform layer was separated and evaporated to

dryness where the obtained residue was dissolved quantitatively in 100ml of acetonitrile (final

conc. 1mg/ml).

For BNZ & FME: An accurate weight of drug (100mg) was dissolved in 100ml of acetonitrile to

give a concentration of 1000µg/ml. The prepared standard stock solutions were further

diluted according to the requirement for their analysis.

DETERMINATION OF DRUGS IN DOSAGE FORM

Vilazodone hydrochloride (Viibryd): Fifteen tablets were weighed, finely powdered and an

accurately weighed sample of powdered tablets equivalent to 50mg of Vilazodone

hydrochloride was dissolved in 50ml of distilled water in a 50ml calibration flask and transferred

into a 125ml separating funnel, where 10ml of 0.1N NaOH solution were added. The mixture

was mixed and extracted three times with 15ml of CHCl3 each, and then the chloroform layer

was separated and evaporated to dryness where the obtained residue was dissolved and then

diluted to obtain a concentration in the range of linearity previously determined with pure

drug.

Dronedarone hydrochloride (Multaq): Ten tablets were weighed, finely powdered and an

accurately weighed sample of powdered tablets equivalent to 50mg of Dronedarone






drug.

Brinzolamide (Befardin): Ten tablets were weighed, finely powdered and an accurately

weighed sample of powdered tablets equivalent to 50mg of Brizolamide was transferred into

50ml validation flask and dissolved in about 50ml of methanol. The contents of flask were

sonicated for 10 minutes. The mixture was filtered through Whitman filter paper and

evaporated to dryness. Residue was dissolved in acetonitrile and then diluted to obtain a

concentration in the range of linearity previously determined with pure drug.



Donepezile hydrochloride (Aricept): Twenty tablets were weighed, finely powdered and an

accurately weighed sample of powdered tablets equivalent to 50mg of Donepezile






drug.

Fexofenadine methyl ester (Allegra): Fifteen tablets were weighed, finely powdered and an

accurately weighed sample of powdered tablets equivalent to 50mg of Fexofenadine methyl

ester was transferred into 50ml validation flask and dissolved in about 50ml of methanol. The

contents of flask were sonicated for 10 minutes. The mixture was filtered and evaporated to

dryness. Residue was dissolved in acetonitrile and then diluted to obtain a concentration in the

range of linearity previously determined with pure drug.

RESULTS AND DISCUSSION

The p-Chloranilic acid solution of 4.78×10-3M in acetonitrile was freshly prepared. Aliquots of

drugs (0.5-2.5ml) were transferred into a series of 10ml calibrated flasks, to each flask, 1 ml of

p-CA solution in acetonitrile was added and remaining volume was made up by acetonitrile. The

absorbance of purple colored solution was recorded after 5min of mixing against reagent blank

at 585nm was plotted against the corresponding concentrations (µg/ml) of the drug to

construct the calibration curve.

Concentration of Drug (µg/ml)

Fig. (2): Calibration curves of p-CA with (1) Dronedarone, (2) Fexofenadine methyl ester, (3)

Brizolamide, (4) Vilazodone & (5) Donepezile.

0 10 20 30 40 50 60 70 80 90 100 110

0.0

0.2

0.4

0.6

0.8

1.0

1.2

Abso

rban

ce(5

) Abs

orba

nce

of D

onep

ezile

+ 0

.3

5

4

32

1



EFFECT OF SOLVENT

Both polar and non-polar solvents such as methanol, acetone, chloroform, 1, 2-dichloroethane

and acetonitrile were used to select elegant solvent for the analysis of drugs. Acetonitrile is

found to be suitable solvent for p-CA it produces maximum absorbance with a fixed

concentration of drugs, while other solvents produced lower absorbance due to incomplete

dissociation of complex.

EFFECT OF CONCENTRATION OF ACCEPTOR

To establish the optimum concentration of reagent, Vilazodone hydrochloride 45 µg/ml,

Dronedarone hydrochloride 25 µg/ml, Brizolamide 25µg/ml, Donepezile hydrochloride 20

µg/ml and Fexofenadine methyl ester 50 µg/ml were react with different volumes of p-CA

(4.78×10-3M). The results showed that the highest absorbance was obtained with 1ml. Hence

1ml of reagent was used for the determination of drugs.

Fig. (3).Effect of volume of reagent on the optical density of the CT complex of p-CA with (1)

Vilazodone, 2) Brinzolamide, 3) Dronedarone & 4) Donepezile.

EFFECT OF REACTION TIME

The interaction of p-CA with drugs resulted in the formation of Charge transfer complexes

which stabilized with in 6 min of mixing. The developed color remained stable at room

temperature for about an hour. After a day all solutions are decolorized.

0.0 0.5 1.0 1.5 2.0 2.5 3.0

0.15

0.20

0.25

0.30

0.35

0.40

0.45

0.50

0.55

0.60

4

3

2

1

Abso

rban

ce

Volume of reagent (ml)



Fig (4): Effect of reaction time on formation of charge transfer complex of p-CA with (1)

Donedarone, 2) Donepezile & 3) Brinzolamide.

VALIDATION OF THE PROPOSED METHODS

The methods developed have been validated in terms of guidelines of international conference

of harmonization viz., selectivity, sensitivity, precision, accuracy, linearity, LOD, LOQ. Sandell’s

sensitivity and robustness. The methods are selective and can differentiate the analyte from the

excipients. The precision is tested by repeating each experiment at least 6 times while the

accuracy has been tested by taking known weight of sample and performing recovery

experiments. The values %RSD are in the permissible range of experimental errors. (Table

2).Sandell’s sensitivity (ss), LOD and LOQ have been calculated by using the following equations.

Sandell’s sensitivity (ss) = 0.001/S

LOD = 3.3s/S

LOQ = 10s/S.

Where s = standard deviation of the intercept (n = 6)

S = slope of Calibration plot.

The robustness of the methods is examined by performing the experiments on three different

Spectrophotometers with excellent tally of absorbance values.

The methods developed have also been applied for the analysis of pharmaceuticals. The

recovery experiments performed show high accuracy and precision and the results are

compared with the available validated reported methods on each drug. The values %RSD and t-

and F tests are in the permissible range of experimental errors (Table 3), and show that the

methods can be used in both pharmaceutical and drug industries.

0 2 4 6 8 10 12 14 16

0.36

0.40

0.44

0.48

0.52

0.56

0.60

0.64

3

2

1

Abso

rban

ce

Time (min)



STABILITY CONSTANTS OF CHARGE TRANSFER COMPLEX

Benesi - Hildebrand method (BH) is used for determination of stability constant K and molar

absorption coefficient of the charge transfer complexes

A0/d = 1/K (D0) € + 1/€

Where A0 = conc. of acceptor, d= optical density, D0 = conc. of drug, €=Molar absorption

coefficient and K= stability constant.

A plot of A0/d Vs 1/D0 is a straight line from whose slope and intercept the K and € are

determined. Benesi – Hildebrand plot of selected drugs with p-CA is presented in (Fig-5).

Fig (5): Benesi-Hildebrand plot of p-CA with (1) Brizolamide, 2) Fexofenadine methyl ester, 3)

Dronedarone, 4) Vilazodone & 5) Donepezile.

STOICHIOMETRY

The stoichiometry of each of the complex has been determined from Job’s continuous variation

method and found to be 1:1 in each case. A typical Job’s plot of selected drugs with p-CA is

presented in (Fig-6).

0.00 0.02 0.04 0.06 0.08 0.10 0.12 0.14 0.16 0.18 0.20 0.22

0.005

0.010

0.015

0.020

0.025

0.030

0.035

0.040

0.045

[A0]/d

1/[D0]



Fig (6): Job’s continuous variation plot of p-CA with (1) Vilazodone, (2) Dronedarone & (3)

Brinzolamide

CONCLUSION

p-CA forms charge transfer complexes with selected drugs and exhibits band at 585nm.The

interaction enabled the quantitative determination of these drugs. This method is validated in

terms of precision, accuracy, linearity and robustness. This method relies on the use of simple

and inexpensive chemicals and techniques but provide sensitivity comparable to that achieved

by sophisticated and expensive techniques like HPLC and LC-MS. Thus, they can be used as

alternatives for rapid and routine determination of bulk sample and tablets.

13. ACKNOWLEDGEMENT

The authors are thankful to the Head, Department of chemistry for providing facilities. One of

the authors B. srinivas is thankful to “CSIR New Delhi, for award of JRF”.

Table [1]: Spectral, analytical and statistical parameters of charge transfer complexes of drugs

with p-CA.

Parameters VZL DND BNZ DPZ FME

λ max, nm 515 515 515 515 515

Beer’s law limit (μg/ml) 15-75 15-75 5-25 20-100 20-100

Molar absorptivity(L mol-1 cm-1) 1.32×104 2.16×104 2.61×104 9.14×104 1.76×104

Slope(specific absorptivity),b 0.0287 0.0197 0.0219 0.0196 0.0155

Intercept, a 0.0243 0.0127 0.0406 0.3555 0.0132

0.0 0.2 0.4 0.6 0.8 1.0

0.05

0.10

0.15

0.20

0.25

0.30

0.35

0.40

0.45

0.50

0.55

Abso

rban

ce

Mole Fraction

3

2

1



Correlation coefficient, r 0.9979 0.9994 0.9998 0.9992 0.9976

Sandell’s sensitivity(μgcm-2) 0.1149 0.0507 0.0456 0.0510 0.1818

Formation constant, K(M-1) 680 514 1818 724 320

SD of intercepts (n=6) 0.0068 0.0072 0.0023 0.0122 0.0015

LOD (μg/ml) 0.7818 1.2060 0.3465 0.1132 3.3212

LOQ(μg/ml) 2.3693 3.6548 1.0502 0.3431 0.9677

Regression equation y=a+bx;

x=concentration of drug(µg/ml)

0.0243

+

0.0087x

0.0127

+

0.0197x

0.0406

+

0.0219x

0.3555

+

0.0196x

0.0132

+

0.0055x

Table 2 Determination of accuracy and precision of the methods on pure drug Samples

Drug Amount taken

(µg/ml)

Amount Found

(µg/ml)

%Recovery % RSD Proposed

Mean ± SD

VLZ

15

30

45

14.97

30.06

45.10

99.80

100.20

100.22

0.2367

100.07

±

0.2369

DND

30

45

60

29.89

44.95

59.75

99.63

99.88

99.58

0.1612

99.69

±

0.1607

BNZ

5

10

15

5.02

9.98

15.08

100.4

99.80

100.53

0.3884 100.24

±

0.3894

20 20.09 100.45 0.6059 99.77



Table 3 Results of assay of tablets by the proposed methods and statistical evaluation and

recovery experiments by standard addition method.

DPZ 40

60

39.84

59.57

99.60

99.28

±

0.6046

FME

40

60

80

39.87

59.76

80.13

99.67

99.60

100.16

0.3056

99.81

±

0.3051

Tablets

Drug in

tablet

(µg/ml)

Drug

added

(µg/ml)

Total

Found

(µg/ml)

%

Recovery

%

RSD

Proposed

Mean

± SD

Ref

Mean

± SD

t-test

F-test

Viibryd

(VLZ)

0.50

0.50

0.50

15.0

30.0

45.0

2.0

4.0

6.0

0.0

0.0

0.0

2.48

4.51

6.49

15.08

30.03

45.08

99.20

100.22

99.84

100.53

100.10

100.17

0.4544

100.03

±

0.66

100.01

±

0.4545

0.485

(3.18)

0.474

(5.28)

Multaq

(DND)

0.50

0.50

0.50

30

45

60

6.0

8.0

10.0

0.0

0.0

0.0

6.48

8.50

10.03

29.99

44.97

59.95

99.69

100.00

100.30

99.96

99.93

99.91

0.1966

99.74

±

0.389

99.96

±

0.1966

1.082

(2.44)

0.255

(3.05)

0.50 1.0 1.50 100.00



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